Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00580190

Purpose

PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors. Demonstration of a statistically significant attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound. Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following naloxone challenge in healthy subjects.

Condition	Intervention	Phase
Healthy	Drug: alprazolam Other: Placebo Drug: PF-00572778	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Pharmacodynamics Study
Official Title:	A Phase I, Randomized, Placebo Controlled, Parallel Group, Single Dose Study To Evaluate The Effects Of PF-00572778 And Alprazolam On A Naloxone Challenge In Healthy Adult Subjects

Resource links provided by NLM:

Drug Information available for: Alprazolam Naloxone

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum observed serum concentration (Cmax) [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
Time to reach the maximum observed serum concentration (Tmax) [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical examinations [ Time Frame: 34 days (weekly) ] [ Designated as safety issue: Yes ]
Peak concentrations for plasma cortisol and ACTH [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast) [ Time Frame: 2nd day on treatment (Days 6-7) ] [ Designated as safety issue: No ]
Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	September 2007
Study Completion Date:	February 2008

Arms	Assigned Interventions
1: Active Comparator	Drug: alprazolam tablet, 0.5 mg, single dose, only on Day 7 of the study
2: Placebo Comparator	Other: Placebo solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study
3: Experimental	Drug: PF-00572778 solution, 500 mg, single dose, only on Day 7 of the study

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 45 years; Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Family (1st degree relatives) and personal history of meeting Diagnostic and Statistical Manual -IV (DSM-IV) criteria for alcohol abuse or dependence.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580190

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8821006
Study First Received:	December 20, 2007
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00580190 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Pharmacologic Actions
Alprazolam
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010